MAUDE Adverse Event Report: BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET; BLOOD SPECIMEN COLLECTION DEVICE

Model Number	367324
Medical Device Problem Codes	Fluid/Blood Leak (1250); Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/27/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported when using the bd vacutainer® push button blood collection set there was blood leakage or other sample leakage from the device other than the insertion site or needle tip and failure of the product to contain blood/medication.The following information was provided by the initial reporter.The customer stated: "there was blood leakage from a damage on the tubing that occurred.".
Additional Manufacturer Narrative
B.3.Date of event: unknown.The date received by manufacturer has been used for this field.H.3.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Additional Manufacturer Narrative
Bd received one used 23g pbbcs and four photos for investigation.The photos were reviewed and the customer¿s indicated failure mode for a leak was observed.The samples were tested and the indicated failure mode for a leak was observed.A gross visual inspection of the returned unit found that a tear was present on the extension tubing near the luer adapter.The tear was small and ran perpendicular to the length of the extension tubing.Flushing the unit confirmed that the unit leaked from the observed tear.Further inspection of the tear under a microscope found that small portions of the tear appeared to have material missing.Based on a review of the device history record for the incident lot, all product specifications and requirements for lot release were met.There were no related quality issues during manufacturing of the product.This complaint has been confirmed for the indicated failure mode of a leak; however, bd was not able to identify a root cause for the indicated failure mode.H3 other text : see h.10.
Event or Problem Description
It was reported when using the bd vacutainer® push button blood collection set there was blood leakage or other sample leakage from the device other than the insertion site or needle tip and failure of the product to contain blood/medication.The following information was provided by the initial reporter.The customer stated: "there was blood leakage from a damage on the tubing that occurred.".

• Brand Name: BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET
• Common Device Name: BLOOD SPECIMEN COLLECTION DEVICE
• Manufacturer (Section D): BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.; 9450 south state street; sandy UT 84070
• Manufacturer (Section G): BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.; 9450 south state street; sandy UT 84070
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8448235433
• MDR Report Key: 16744049
• Report Number: 1710034-2023-00418
• Device Sequence Number: 5378012
• Product Code: JKA
• UDI-Device Identifier: 50382903673242
• UDI-Public: 50382903673242
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K030573
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Expiration Date: 05/31/2024
• Device Model Number: 367324
• Device Catalogue Number: 367324
• Device Lot Number: 2131350
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/28/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/27/2023
• Supplement Date Received by Manufacturer: 05/03/2023
• Initial Report FDA Received Date: 04/14/2023
• Supplement Report FDA Received Date: 05/10/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/02/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown